HYDROXYUREA capsule

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

HYDROXYUREA (UNII: X6Q56QN5QC) (HYDROXYUREA - UNII:X6Q56QN5QC)

Commercializzato da:

Physicians Total Care, Inc.

INN (Nome Internazionale):

HYDROXYUREA

Composizione:

HYDROXYUREA 500 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Significant tumor response to hydroxyurea capsules USP has been demonstrated in melanoma, resistant chronic myelocytic leukemia, and recurrent, metastatic, or inoperable carcinoma of the ovary. Hydroxyurea, USP used concomitantly with irradiation therapy is intended for use in the local control of primary squamous cell (epidermoid) carcinomas of the head and neck, excluding the lip. Hydroxyurea is contraindicated in patients with marked bone marrow depression, i.e., leukopenia (< 2500 WBC) or thrombocytopenia (< 100,000), or severe anemia. Hydroxyurea capsules are contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of its formulation.

Dettagli prodotto:

Hydroxyurea capsules USP 500 mg are available as a two-piece hard gelatin capsule with purple opaque cap and pink opaque body filled with white powder, imprinted in black ink barr 882 and packaged in Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). STORE IN A DRY ATMOSPHERE AND AVOID EXCESSIVE HEAT. WEAR GLOVES AT ALL TIMES WHEN HANDLING CONTAINERS. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

HYDROXYUREA - HYDROXYUREA CAPSULE
PHYSICIANS TOTAL CARE, INC.
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HYDROXYUREA CAPSULES USP
RX ONLY
DESCRIPTION
Hydroxyurea capsules USP are an antineoplastic agent available for
oral use as capsules providing 500
mg hydroxyurea, USP. Inactive ingredients: anhydrous citric acid,
benzyl alcohol, black iron oxide,
butylparaben, carboxymethylcellulose sodium, D & C red no. 28, D & C
yellow no. 10 aluminum lake,
dibasic sodium phosphate, edetate calcium disodium, FD & C blue no. 1,
FD & C blue no. 1 aluminum
lake, FD & C blue no. 2 aluminum lake, FD & C red no. 40, FD & C red
no. 40 aluminum lake, gelatin,
lactose monohydrate, magnesium stearate, methylparaben, pharmaceutical
glaze, propylparaben,
propylene glycol, red iron oxide, sodium lauryl sulfate, sodium
propionate, and titanium dioxide.
Hydroxyurea is an essentially tasteless, white crystalline powder. Its
structural formula is:
CH N O M.W. 76.05
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
The precise mechanism by which hydroxyurea produces its antineoplastic
effects cannot, at present, be
described. However, the reports of various studies in tissue culture
in rats and humans lend support to
the hypothesis that hydroxyurea causes an immediate inhibition of DNA
synthesis by acting as a
ribonucleotide reductase inhibitor, without interfering with the
synthesis of ribonucleic acid or of
protein. This hypothesis explains why, under certain conditions,
hydroxyurea may induce teratogenic
effects.
Three mechanisms of action have been postulated for the increased
effectiveness of concomitant use of
hydroxyurea therapy with irradiation on squamous cell (epidermoid)
carcinomas of the head and neck. _In_
_vitro _studies utilizing Chinese hamster cells suggest that
hydroxyurea (1) is lethal to normally
radioresistant S-stage cells, and (2) holds other cells of the cell
cycle in the G1 or pre-DNA synthesis
stage where they are most susceptible to the effects of irradiation.
The third mechanism of action has
been theorized on the basis of _in vitro _studies of HeLa cell